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中等剂量促红素每周单次与分次给药治疗肾性贫血的安全性探讨

摘要:背景 多个研究表明重组人促红素注射液(rHuEPO)治疗肾性贫血的给药频率不影响治疗效果,每周单次给药与分次给药疗效无显著差异,临床中大部分血液透析患者使用中等剂量rHuEPO,而对于中等剂量rHuEPO单次给药与分次给药的安全性研究较欠缺。目的 探讨中等剂量rHuEPO每周单次与分次给药治疗维持性血液透析患者肾性贫血安全性差异。方法 本研究采用随机、平行对照、非劣效性临床试验设计。选取2019 年1月至 2021年5月于北京中医药大学东直门医院通州院区血透室进行维持性血液透析的88例患者,随机分为两组,每组44例,试验组为rHuEPO每周单次给药,分为6000IU(试验1组)、4000IU(试验2组)两个小组,对照组为rHuEPO每周分次给药,分为6000IU(对照1组)、4000IU(对照2组)两个小组。比较试验组与对照组的安全性指标及疗效指标。结果 安全性指标:试验组与对照组收缩压、舒张压、平均动脉压的组间与时间交互作用均无统计学意义(P>0.05),组间及时间对收缩压、舒张压、平均动脉压水平的主效应均无统计学意义(P>0.05);组间与时间对两组透前血钾的交互作用无统计学意义(P>0.05),组间及时间对透前血钾水平的主效应无统计学意义(P>0.05);AST、ALT水平保持稳定,无明显升高现象;各组患者均未出现血栓栓塞、心脑血管事件及与rHuEPO相关的胃肠道反应。疗效指标:试验组治疗12周后血红蛋白不劣于对照组,红细胞计数、红细胞压积、网织红细胞百分比、网织红细胞绝对值均值无显著差异(P>0.05),铁蛋白、转铁蛋白饱和度均值无显著差异(P>0.05)。结论 中等剂量组rHuEPO每周单次给药治疗维持性血液透析患者肾性贫血与分次给药在安全性方面无显著差异。临床试验注册 中国临床试验注册中心,注册号:chiCTR2100050894

英文摘要:Background Many studies have shown that the frequency of administration of recombinant human erythropoietin(rHuEPO)injection in the treatment of renal anemia does not affect the efficacy, and there is no significant difference between weekly single administration and divided dosage administration. Most hemodialysis patients use rHuEPO with medium dosage in clinic, but there are few safety studies on weekly single administration and divided dosage administration of rHuEPO with medium dosage.Objective To explore the safety difference between weekly single administration and divided dosage administration of rHuEPO injection with medium dosage in the treatment of renal anemia in maintenance hemodialysis patients.Methods Randomized, parallel controlled and non-inferior clinical trial design was adopted in this study. 88 patients undergoing maintenance hemodialysis in the hemodialysis center of TongzhouBranch of Dongzhimen Hospital of Beijing University of Chinese Medicine from January 2019 to May 2021were selected and randomly divided into two groups, with 44 patients in each group. The experimental group was given rHuEPO injection once a week, while the control group was given rHuEPO injection with divided dosage administration.Both groups divided into 6000IU and 4000IU groups. The safety indexes and efficacy in experimental groups and control groups were compared. Results Safety index: There was no significant difference in the interaction effect of systolic blood pressure, diastolic blood pressure and mean arterial pressure between the experimental group and the control group (P>0.05), and there was no significant difference in the main effect of systolic blood pressure, diastolic blood pressure and mean arterial pressure between the groups and times (P>0.05); There was no significant interaction between the two groups of blood potassium before dialysis (P>0.05), and the main effect of groups and times on pre dialysis blood potassium level was not statistically significant.The levels of AST and ALT remained stable without significant increase. There were no thromboembolism, cardiovascular and cerebrovascular events and gastrointestinal reactions related to rHuEPO in all groups. Efficacy index: After 12 weeks of treatment, the hemoglobin of the experimental groups was not inferior to that of the control groups. There was no significant difference in erythrocyte count, hematocrit, reticulocyte percentage and reticulocyte absolute value(P>0.05),and there was no significant difference in the mean value of ferritin and transferrin saturation(P>0.05).Conclusion There was no significant difference in the safety of rHuEPO injection with medium dosage between weekly single administration and divided dosage administration in the treatment of renal anemia in maintenance hemodialysis patients. Trial registration Chinese Clinical Trial Registry,Registration number:chiCTR2100050894

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[V1] 2022-08-12 18:31:10 chinaXiv:202208.00081V1 下载全文
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